Brand Name | SIGMA 300 S |
Type of Device | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
Manufacturer (Section D) |
IPG MFG SWITZERLAND |
route du molliau 31 |
tolochenaz 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
8200 coral sea st ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 4362795 |
MDR Text Key | 5112910 |
Report Number | 9614453-2014-03127 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P980035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/07/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/28/2007 |
Device Model Number | SS303U |
Device Catalogue Number | SS303U |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/07/2014
|
Initial Date FDA Received | 12/26/2014 |
Date Device Manufactured | 07/07/2006 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 00009 YR |
|
|